Monday, March 30, 2009
What's the right price for a kidney? (Marin IJ)
For instance, how much cash would it take for you to sell a kidney? Keep in mind that you have two kidneys, but can do just fine with one, so long as it is functioning well. Of course, if you give up a kidney and the remaining one is later damaged (because of trauma, infection or diabetic complications) things will no longer be just fine.
I should also mention that removing a kidney is not a trivial process: it requires surgery and general anesthesia, and there's the possibility of surgical complications including death (less than 1 percent of the time). Consider also that the selling of organs is deemed unethical by most bioethicists and organ transplant organizations and that it is illegal in the United States and other Western countries. But even knowing all this, I bet if you ponder it long enough, you have a price. So, what is it? A comfortable retirement? Your daughter's college education? Twenty minutes alone with Bernie Madoff?
Before you decide, you might be interested in the going price for one working kidney elsewhere in the world. In Iran, where organ sales are legal, it is $5,000 to $6,000. According to the parliament of Singapore, which is considering legalization of organ sales, the proposed ceiling price for a kidney would be $33,000. In India, where organ sales used to be legal and a black market now flourishes, compensation averages around $1,250. That's according to the San Francisco Chronicle, which ran a piece last year describing India's illicit organ trade, a trade that pivots on the practice of buying organs for cheap from India's working poor and selling them for much more to wait-listed foreigners.
In San Diego County, the kidney of a healthy 22 year-old "nondrinker" was recently offered on craigslist for "$100K obo, plus any medical expenses." But, that may be overly optimistic. In 2003, Nobel Laureate economist Gary S. Becker performed a market analysis that predicted a U.S. commodity price of significantly less than that - $45,000.
It doesn't seem quite right to discuss what the market price of a kidney might or should be, but we've reached the point where, no matter how unpleasant, the topic needs to be addressed. Worldwide, the demand for viable organs continues to increase, and in the United States it's estimated that 17 people die each day while waiting for a donor.
Various strategies, such as public relations efforts and state drivers license advance permissions, have failed to significantly improve cadaveric donor rates.
Internationally, success rates are somewhat better because of presumed consent (opt-out) and mandated choice (yea or nay required) organ donation laws that streamline the consent process. And, like it or not, the Chinese have successfully harvested organs from tens of thousands of executed criminals.
But yet, nefarious black markets in India and elsewhere thrive. Desperate kidney purchasers, according to the late Israeli transplant nephrologist Michael Friedlander, are "exposed to unscrupulous treatment by uncontrolled free enterprise." And for the paid donors, the treatment is not much better. According to news reports, kidneys sold in India come from laborers such as P. Guna, a 38-year-old rickshaw driver with a fourth-grade education. For Guna, $1,250 is certainly a lot of money, but considering that his kidney was sold for more than $25,000, it sure seems like he was taken advantage of.
As with other illicit trades (such as recreational drugs and prostitution), one could argue that legalization of organ buying and selling would allow for regulation, and regulation could protect the sick as well as the poor and disadvantaged. In Iran, for instance, the legalization of organ selling has eliminated the waiting list for kidney transplants, and it is certainly possible that a similar policy could do the same here. Ultimately, though, this issue will remain a sticky one as long as the demand for organs outstrips the supply from cadavers or until we are able to grow new kidneys in a laboratory.
So, my question is not merely of hypothetical interest, it is also of practical public health policy interest. What is your price? What is a fair market price? What should have Guna's price been?
Saturday, March 28, 2009
Heads Up (Marin IJ)
Several years ago, while working at a county hospital, I treated a patient with an unusual head injury. The young man was with his girlfriend, in the midst of a heated argument, when he abruptly exited her vehicle, while it was traveling at highway speed. He hit the asphalt, head first, and rolled off the freeway. In the Emergency Department (ED), an hour or so later, he was seemingly unfazed by the incident. The only external signs of trauma were some scrapes and an eggplant-like lump over his temple. I was surprised at how good he looked, considering that he’d jumped out of a moving car, but also suspicious. I sent him over for a CAT scan of the head (Head CT) and, by the time he returned, he was nearly comatose. I looked in his eyes and saw that one pupil was twice the size of the other, a sign that his brain was being badly squeezed.
I thought about this patient recently as I was reading of the tragic death of actress Natasha Richardson. Richardson, for those who have been in news hibernation for the last six weeks, died last month after falling on a beginner’s ski slope. Richardson and my car-ditching patient each developed an epidural hematoma – a blood collection in the epidural space between the skull and the brain. Epidural hematomas, which are a relatively rare type of head injury, are usually caused by a fracture of the temple (temporal bone) and bleeding from the artery beneath it. In both these instances, the bleeding ballooned, compressing the brain like a pinched grape. The important difference between the two cases was that my patient, unlike Richardson, was transported by ambulance to a trauma center with an in-house neurosurgeon – who whisked him to the operating room.
The delay in transferring Richardson to a trauma center was one of several aspects of her story that received significant media attention. Some of this media exposure was helpful – alerting the public to the warning signs associated with severe head injuries. Take, for example, the seven year-old girl in Ohio who complained of a horrible headache two days after being struck in the temple by a batted baseball. Her parents, who were watching coverage of the Richardson story on CNN, brought her to the ED just in time to receive treatment for an expanding epidural hematoma.
Some of the media coverage, on the other hand, was less helpful. One online article stated that clot busting drugs might be used to treat a blood collection in the brain, which, in actual fact, would cause more bleeding and be a very bad idea. Another advised head injured patients be seen at a trauma center – which is a good plan for someone who has taken a header off the roof onto the driveway – but not necessary for most head bonks. Others repeated the myth that head injured patients be woken up every hour at night, a practice that accomplishes only one thing – a poor night’s sleep for everyone involved. And finally, a rather alarmist blog advised that all patients with head trauma be screened with a Head CT. It seems as though some folks are taking this advice seriously – in the last few weeks I’ve evaluated a handful of minor head injured patients who have requested a Head CT. This may seem reasonable until you consider that about 90% of Head CTs ordered for trauma patients are completely normal and that they involve significant doses of radiation that may be harmful, especially to the developing brain. So, how does a doc decide who needs a CT and who can go home radiation-free?
Fortunately, researchers in the U.S. and Canada have developed a number of research-based guidelines that are extremely accurate in ruling out head injuries that require surgical treatment. For example, the Canadian CT Head Rule, derived from a study of over 3000 adults with a symptomatic head injury (confusion or amnesia at the time of trauma) is 100% accurate at predicting which patients are safe without a CT. The full details of the rule are too lengthy for this column, but essentially they boil down to this: you need a CT if you have any of the following: age greater than 65, repeated vomiting, persistent confusion, or evidence of a skull fracture (like an eggplant over your temple or clear fluid draining from your nose).
Of course, I’m not suggesting that you try to evaluate yourself with these guidelines at home. I just want you to know that if you hit your head and go to the ED and your doctor says that you don’t need a CT, he or she has probably used a proven tool to help make this decision.
Aside from the importance of appropriate evaluation and treatment of head injuries, there’s another important take-away from the Richardson tragedy. And that has to do with prevention; wearing a helmet is nearly 100% protective against epidural hematomas. Now, a helmet cannot protect against severe brain shaking or bruising, such as might occur in a car accident, but it can shelter you from direct trauma to the temporal bone. This is why baseball players wear helmets while at bat (the first major league player ever killed on the field - Ray Chapman- was an unhelmeted batter struck in the temple by a pitch). And this is why 21 states and numerous municipalities have made it mandatory for children to wear helmets while riding their bicycles (helmets are 85% effective in lessening the severity of head injuries from bike crashes.) I am not arguing that we all walk around wearing helmets, that would make for a lot of bad hair days, but perhaps people learning a high velocity sport, like skiing, should be advised to. As for jumping out of cars, helmet or no-helmet, this is not a recommended activity. My patient did well after surgery, but I don’t imagine he will be trying that stunt again.
Sunday, March 22, 2009
Don't Blame it on the Shots (Marin IJ)
Dr. Dustin Ballard: Don't blame autism on shots
Before you rush out to stock up on pints of Cold Stone Creamery and shares of Ben & Jerry's, I should mention that people eat more ice cream in the summer. They are also more active and have higher metabolic rates in warmer weather. So, perhaps it's not the ice cream that leads to weight loss but rather seasonal variation in calorie burning. What's the lesson here? That causality can be elusive.
Causality, for those not familiar with the term, simply means "cause and effect." Determining whether there is genuine causality between two entities, rather than a chance association or one unduly influenced by unrecognized factors (called confounders), is difficult. For example, many people still believe that exposure to cold weather causes pneumonia. But it's actually not the chilly weather that increases the risk of pneumonia, it's that during the cold winter months people stay inside and are in closer contact with other people's germs. Proving a clear-cut link between a dietary item, personal habit or medical treatment and a disease process is fraught with the potential for misinterpretation.
Consider the proposed connection between routine childhood vaccinations and autism. The diagnosis of childhood autism is on the rise and we don't know why. Since the 1990s, autism rates have increased by 700 percent to 800 percent.
As a parent, I have experienced a good deal of anxiety about the possibility that the routine measles-mumps-rubella (MMR) vaccine and/or a mercury-based additive (thimerosal) once used in children's vaccines could be responsible for the incredible spike in autism- especially since this spike has hit close to home.
I have a niece and nephew who have each been diagnosed with an autism spectrum disorder and my wife has repeatedly agonized about the immunization process for our own children. But as a medical professional, I have unabashedly preached that routine immunization programs are critically important for the public's health. After all, vaccination efforts have a proven track record: they eradicated smallpox and made polio a disease only seen in paranoid communities (such as the Nigerian province that banned immunizations because they believed they were a Western plot to sterilize their children.) Thus, when I was confronted with the possibility that routine shots could permanently alter the neurochemistry of my children, my friends' children, or anyone's children, I was frightened. Even more so because the alternative to community vaccination is a free-for-all of childhood diseases and, as in Nigeria, the widespread return of a horrible illness like polio.
Fortunately, my fears have been allayed by the alignment of an overwhelming preponderance of medical research against the vaccines-cause-autism hypothesis. Last month, a federal court considering this question ruled in favor of the U.S. government, clearing immunizations of causality. Special Master George L. Hastings Jr., after reviewing 5,000 pages of testimony, concluded that the government's expert witnesses were "far better qualified, far more experienced and far more persuasive" than those of the plaintiffs.
Additionally, a California Department of Health study released last year found that autism rates in the state rose continuously from 1995 through 2007, despite the fact that thimerosal was removed from all vaccines (except some flu shots) in 2001. Since signs of autism usually surface by age 3, one would expect that if thimerosal in vaccines was the problem, the autism diagnosis rates would have dropped between 2004 and 2007. They did not. This simple finding, which is supported by a number of other rigorous investigations, is compelling evidence that researchers will have to look elsewhere for the cause of the autism epidemic.
In contrast, the primary scientific evidence supporting a link between vaccines and autism is a small study published in the medical journal Lancet in 1998 - a study that has been thoroughly discredited. Since its publication, it has come to light that there was a conflict of interest (the research was secretly funded by plaintiff lawyers) and that the data was falsified. Its findings (linking intestinal inflammation with the MMR immunization and subsequent autism) have not been replicated in larger studies and have been repudiated by 10 of the paper's 13 authors.
Why, with all of this evidence, is there a persistent perception that vaccines cause autism? It's kind of like ice cream and weight loss in the summertime. People eat ice cream during the time of year when they are most likely to lose weight. Children are diagnosed with autism at around the same time as they receive vaccinations. Virtually every child who has autism will have also been immunized, and in some rare cases, children with underlying immune or metabolic disorders may have their inevitable symptoms unmasked by vaccination. Thus it is easy to stray down the path to mistaken association.
But, if it's not the shots, what is it?
That's tricky, too. There are other suspects; genes, environmental toxins and television have been implicated. But it seems that a significant culprit is increased awareness among parents and physicians of the behavioral and cognitive manifestations of autism. With increased awareness comes increased recognition and diagnosis.
Still, no matter how persuasive the evidence proving otherwise, some people will remain fixated on vaccines as the agents of autism. This is unfortunate and shortsighted. Failure to vaccinate children can have real and deadly consequences. There are many parents out there who might say. "Well, my child didn't get vaccinated, and she didn't get sick." Those parents should know that is the reason their child didn't become ill is because the vast majority of the other kids in their community did get vaccinated. But if enough of those other children don't get vaccinated, more children will get sick.
So, it is time to turn our attention to other possible causes and treatments for autism and leave the vaccines alone. No medical treatment is completely risk-free, but routine childhood immunizations are clear winners in any cost-benefit analysis. Despite its indisputable deliciousness, the same cannot be said of ice cream.
For more information about the importance of this issue in Marin County, contact Dr. Clark Hinderleider of the Health Council of Marin at: CLARKMDPH@aol.com
Dr. Dustin W. Ballard is an emergency physician at Kaiser Permanente San Rafael and the author of "The Bullet's Yaw: Reflections on Violence, Healing and an Unforgettable Stranger." His Medically Clear column appears every other Monday.
Tuesday, March 3, 2009
Medicine's Price Tag Problem (Marin IJ)
Dr. Dustin W. Ballard
Posted: 01/18/2009 06:29:52 PM PST
http://www.marinij.com/lifestyles/ci_11482679
Have you ever bought a bottle of wine, one that you knew absolutely nothing about, because it was expensive? I have.
I am not a wine aficionado, in fact, I couldn't tell you a single difference between a merlot and a cabernet sauvignon and, if I'm called upon to describe a wine's flavor, I will usually respond that it is "slightly dusty with a gravely finish." But, occasionally, I am asked to bring a bottle of wine to a social gathering and in these instances I don't want to disappoint. So, I go to an upscale grocer and look for an upscale bottle: one with an artistic label and a price that will ensure that the hosts do not think of me as cheap.
Now, it is possible that the wine I choose is worth it, but it is also possible that it is not, and it is unlikely that I will be able to discern the difference. Either way, I have fallen prey to a strategy that marketers call "premium pricing," based on generating the impression that because the cost of an item is high, it must have exceptional attributes.
Take a moment and I'm sure you can think of a situation where premium pricing has won you over - a beauty product or accessory perhaps, or choosing high octane gasoline, or justifying an art purchase as "an investment"?
Premium pricing, as it turns out, is everywhere, and everywhere includes the business of medicine. And, as in other industries, there are plenty of health consumers who believe that more expensive medical care must mean better medical care.
Take,for example, a recent study published in the Journal of the American Medical Association (JAMA). Eighty-two paid volunteers were given an analgesic (painkiller) before and after a series of electric shocks (10 volts to 80 volts) to the wrist. The patients were told that the painkiller was similar to codeine, but newer and quicker acting. Actually, it was nothing more than a placebo (sugar pill).
All the study subjects were given the same treatment, but half of them were told that the medicine cost $2.50 a pill while the other half were told that it cost just 10 cents a pill. Even though the therapy (or lack thereof) was completely the same in the two groups, 24 percent more (85 percent versus 61 percent) volunteers in the high-priced group reported a reduction in pain scores after treatment. These results were consistent across all voltage intensities tested.
This finding is quite astonishing; a sugar pill combined with premium pricing will cause more than eight out of 10 people to report a positive effect. The results speak to the power of suggestion and expectation to affect clinical response. And they also help explain why so many patients prefer brand name to generic medicines - even when they are the exact same drug. Or, why patients request newer, more-expensive treatments that are no better (and in some cases much worse) than, older, time-tested treatments; stomach acid reducers (Nexium versus Prilosec) and non-steroidal anti-inflammatories (Vioxx versus Motrin) are great examples.
Not everyone in the business of medicine is too concerned about patients paying more for treatments that could be had for much less; in fact the practice seems emblematic of the largess of our health system as a whole. There is a lot of money to be made through the premium pricing of health care and it is a situation where the psychological impact of the strategy is particularly powerful. No one wants to be cheap about his or her health, or that of a loved one, if he or she doesn't absolutely have to be. And, if a third payer, such as Medicare, is going to cover the bill, there is even more reason not to skimp.
It all makes sense, so long as you know what you are getting. But on the other hand, if enough people choose their therapies based on the same rationale I use to choose my wine, the result will eventually be a bankrupt health system.
Dr. Dustin W. Ballard is an emergency physician at Kaiser Permanente San Rafael and the author of "The Bullet's Yaw: Reflections on Violence, Healing and an Unforgettable Stranger." His column appears every other Monday.
Extracting the Bull*&*^* (Marin IJ)
Posted: 02/13/2009
http://m.marinij.com/marin/db_10489/contentdetail.htm;jsessionid=094B96663280D9692E40B21ECE1FBD99?contentguid=7v1CDUaq&storycount=15&detailindex=1&full=true#display
Dr. Dustin Ballard
Several weeks ago, I joined legions of other fans in watching the season premier of ABC's "Lost." This hit series, about plane crash survivors stranded on a mysterious island, has become progressively fantastical with each passing episode. Once again, I was happily suspending disbelief as the "Lost" characters began to bounce haphazardly across a time-space continuum.
But while I find time travel to be a pleasant fictional diversion, I soon saw something that propelled me back to reality. One of my favorite "Lost" characters, John Locke, a survivalist with a messiah-complex, takes a rifle shot to the thigh. Moments later, out of the darkness appears Richard - Locke's ageless island guardian - to save the day. After informing Locke, "You are bleeding to death," and warning him, "This is going to hurt," Richard plunges a pair of forceps into the wound. With a simple turn and tug, he extracts the bullet from Locke's thigh. The next time we see Locke, he is emerging from the jungle with a slight limp, having just single-handedly disabled three hostiles.
This is fun television, but I must take issue with the medical care depicted. I know some of you are thinking "Who cares, it's just a silly TV show," or, "I see this sort of thing in movies all the time," and of course you are right. But keep in mind, even a fantasy like "Lost" (which receives about 10 million to 15 million viewers a week) can shape the viewing public's perception of what constitutes effective medicine. And,
with that concern in mind, let me extract the bull--- from how Hollywood often portrays the treatment of gunshot wounds.
First, bullet extraction is nowhere near as simple as shown on TV. If a bullet does not pass directly through human tissue (exiting out the other side) it is either because the bullet hit the body at extremely low velocity or because it hit something (such as bone) on its way through and was shunted in a different direction. If the bullet has lodged in an extremely superficial location (as in if it's practically sticking out of the skin), it can usually be easily removed, but any meatier location makes extraction exceedingly difficult - and messy.
During my emergency medicine training, a supervising physician and I attempted to remove a bullet from a man's shoulder so that we could hand it over to the police as evidence. On X-ray, the bullet appeared to be just below the skin, but dissecting down to and removing it from the man's shoulder took well over an hour and caused him substantial discomfort.
Another, historically significant example, involves President Garfield who, in 1881, was shot in the back by a disgruntled office-seeker. For the next 80 days, Garfield suffered through doctors' attempts to discern the .44 bullet's resting place. Numerous physicians probed the wound (without using sterile technique) and Alexander Graham Bell even tried to locate the bullet using his new invention, the metal detector. To no avail, the presidential bullet was not found, and Garfield's bungled medical care turned a 3-inch wound into a 20-inch tunnel, massively infected and oozing pus. Who knows - if those doctors had left the wound alone, Garfield may have lived, and avoided the unfortunate distinction of the President with the second shortest tenure in office.
And this brings me to my second point; in most situations, removing bullets does more harm than good. "Removing a bullet embedded in tissue can be a very unsatisfying, bloody experience," says Joseph Galante, assistant professor and trauma surgeon at UC Davis Medical Center. The process, he says Galante "cutting out a lot of healthy tissue, usually muscle" and carries with it "a high risk of infection."
Of course, living with a retained bullet isn't always advisable. There are rare cases of bullets lodged near major veins that loosen and migrate to the heart and several reports of retained bullets degrading (over a very long time) and causing lead poisoning. A bullet trapped in a joint can be extremely painful and I personally wouldn't want a metallic fragment floating around in my bladder and worrying that it might try to sneak out in a very painful manner. But, in the vast majority of cases, bullets cause their damage during their initial passage through the body and not by how they rest afterwards.
For example, a patient with a gunshot wound to the belly requires surgery - not because the bullet needs to be removed (although it usually is), but because it probably caused blood vessel and/or bowel injuries during its travels. Bullets embedded in arms, legs, muscles and superficial tissues, however, rarely need to be extracted. In a study of 28,150 patients with noncritical gunshot wounds (those not penetrating the head, neck, chest or belly) evaluated at a Los Angeles Trauma Center between 1977 and 1991, 60 percent were successfully treated without hospitalization, with a very low (less than 2 percent) complication rate. Of these, 39 percent had bullet parts seen on X-ray; and these were removed less than 1 percent of the time. The majority of these gunshot wounds were successfully treated by observing the famous surgical dictum: "treat the wound, not the weapon."
Thus, in the case of John Locke's gunshot wound, the appropriate treatment should have been to control the bleeding with direct pressure at the site of the wound (and not with the silly tourniquet Locke tries to fashion) and to let the sleeping bullet lie. (Avid "Lost" fans will recognize that it didn't really matter how Locke's wound was treated, because the island has magical healing properties that would have saved him regardless.)
So, is it too much to ask Hollywood to stop propagating the myth of the magical bullet extraction? Or, for that matter, the practice of sucking the venom out of snakebites? Relocating dislocated shoulders by slamming them against walls? Rendering someone instantly and lastingly unconscious with a simple blow to the head? The alternative depictions might not be quite so glamorous, but they would be real, and that would make them refreshingly original.
Dr. Dustin W. Ballard is an emergency physician at Kaiser Permanente San Rafael and the author of "The Bullet's Yaw: Reflections on Violence, Healing and an Unforgettable Stranger." His Medically Clear column appears every other Monday.
With children comes dangerous play (Marin IJ)
Dr. Dustin Ballard
Posted: 02/01/2009 06:04:55 PM PST
Some time ago, I learned about a children's product called "Aqua Dots" that, as it turns out, was the perfect toyÉ for a raver.
Aqua Dots (also known as Bindeez) was an ingenious craft kit that made Etch-A-Sketch look Mesozoic. Using a plastic pneumatic pen, children could set colorful little beads into mosaics and permanently bond their creations simply by adding water - thus creating lasting tributes to their artisanship. Creative, fun and priced under $30, Aqua Dots sold millions of sets and was named Australia's Toy of the Year in 2007.
But there was one problem: if your little Picasso ingested the Skittle-esque Aqua Dots, he might suffer an abstracted level of consciousness, like Pablo in the sky with diamonds. This is what happened to dozens of children, aged 2 to 10, after swallowing Aqua Dots. Several of them were hospitalized with seizures, lethargy and respiratory distress. No children died, but parents and physicians were puzzled until the culprit was identified - Aqua Dots were laced with GHB. GHB, as in the popular club drug from the 1990s, that is known in the media as a "date-rape drug" and on the streets as Scoop, Liquid X, Easy Lay and G-Riffick.
How did a date-rape drug get into a children's art toy? Remember the recent Chinese infant formula scandal? Well this situation involved a similar cost-cutting measure. The Chinese plant manufacturing Aqua Dots decided to substitute a cheaper solvent (1,4-butanediol or 1,4-BD) for its nontoxic counterpart (1,5-pentanediol). When ingested, 1,4-BD is metabolized to gamma-hydroxybutyrate (GHB) and within 15 to 30 minutes severe changes in mental state result.
After the GHB discovery in late 2007, 4.2 million units of Aqua Dots were recalled. Subsequently, the product was renamed "Beados" and marketed as containing a "new bead formula," one without the toxic solvent and with a bitter-tasting additive to discourage ingestion. You can still find it online today (just Google "Beados Beads.")
As frightening as this story is, it is just one of many examples of child's play gone awry. Radar Online has recently hailed Aqua Dots, alongside nine other disastrous inventions, as the "most dangerous playthings of all time." Some of the other ill-considered products included lawn darts (Jarts) that impaled younger siblings, Easy Bake Ovens that toasted little hands, BattleStar Galactica Missile Launchers that fired missiles into mouths and throats, and Johnny Reb Canons that blinded eyeballs with miniature plastic cannonballs.
But, minimalists beware; it's not just specialty toys that can cause problems. Marbles have a strong affinity for the nasal passages of 2-year-old boys and 3-year-old girls have an unfortunate tendency to run around with pencils pointed upwards in a manner that can lead to punctured lips and tongues. Several years ago, I treated a youngster with unusual breathing. The parents thought it might be pneumonia or asthma, but I was befuddled. There was an unusual noise in the child's lungs - something high pitched and squeaky. An X-ray revealed the culprit; a small metal whistle that the child had surreptitiously aspirated (swallowed into the lungs).
Even a balloon, so gentle and buoyant, can be a dangerous hazard. A child who accidentally swallows the remnants of a popped balloon may suffer a horrific airway emergency because a balloon can lodge in the trachea and - because of its elasticity - be difficult to remove. In fact, a study from the Cook County Medical Examiner's Office in Illinois found that toy balloon aspiration was the most common cause of fatal aspiration in children under age 14.
For as long as there have been children, there have been children who discover pain in their play. As any parent can attest, kids are very consistent in when they choose to play dangerously; at exactly the moment mom or dad looks the other way. Short of locking up little Sally in a padded cell, there is really no way to keep your child completely safe. But, it would be reassuring if toy makers would help out just a bit and avoid throwing lawn darts. A good place to start would be to stop confusing terrific toys with G-riffick toys. Leave the latter to the clubbing crowds.
TOY SAFETY
- For tips on choosing safe toys, check out the American Academy of Pediatrics Web site at www.aap.org/publiced/br_toysafety.htm
- For more information about recalled toys, go to the Consumer Product Safety Commission at www.cpsc.gov
Dr. Dustin W. Ballard is an emergency physician at Kaiser Permanente San Rafael and the author of "The Bullet's Yaw: Reflections on Violence, Healing and an Unforgettable Stranger." His Medically Clear column appears every other Monday.
Lessons in a Bottle (Marin Independent Journal)
Dr. Dustin Ballard: Vioxx story linked to debate over U.S. health system
http://www.marinij.com/lifestyles/ci_11810118
Just two weeks ago, President Obama signed into law a $787 billion stimulus bill that establishes a multiagency council tasked with coordinating $1.1 billion of research into the comparative effectiveness of medical treatments. The goal of the federal investment in CER is to provide clear information about the risks, benefits and costs of various treatments of specific diseases (including drugs, supplements, medical devices and procedures).
Given the volume of information and misinformation available in the health-care arena, the work of the Federal Coordinating Council for CER (Council for CER), if done right, would be extremely valuable. Of course, many excellent resources weighing the pros and cons of medical treatments already exist, as do some well-done reviews of existing medical research (such as the Cochrane Review series), but a centralized and trusted catalog of comparisons would have far wider influence.
Still, comparative effectiveness research has its opponents. Sadly, they don't appreciate how CER could improve care. Instead, they fear a slippery slope leading to "rationing." Comparing treatments, they argue, will ultimately lead to certain higher-priced treatments being denied by Medicare and other payers.
George Will, writing about the excesses of the stimulus bill, opined, "CER, which would dramatically advance government control - and rationing - of health care, should be thoroughly debated." Betsy McCaughey, a senior fellow at the Hudson Institute in New York, went further in an op-ed for Bloomberg News, arguing, "Senators should read these provisions and vote against them because they are dangerous to your health."
Debating the benefits of CER is one thing, calling it dangerous is quite another. At this point, the details of the Council for CER are murky, and there is certainly a chance that the effort could go astray, but the dangerous approach is the status quo. If you don't believe me, consider the case of Vioxx.
You probably remember Vioxx (also known as Rofecoxib), the blockbuster drug of the new millennium that went horribly wrong. Vioxx was marketed as an effective painkiller that lacked the gastrointestinal side effects of anti-inflammatories such as ibuprofen and naproxen. A Vioxx-dedicated force of 3,000 Merck representatives canvassed physicians across the land, handing out pamphlets claiming Vioxx to be "8 to 11 times safer" than the competition. As a result, Vioxx had a great run; from May 1999 to September 2004, 100 million prescriptions were written in the U.S. alone and the drug generated billions of dollars in sales. A great run indeed, until it became clear that Vioxx had a nasty side effect - it caused people to die of heart attacks. How many people? Well, that is not exactly clear and may never be.
A colleague asked me recently if I had any idea how many deaths were attributable to Vioxx and I have to admit I was shocked to learn that the number may be as high as 60,000 (based on estimates by FDA official David Graham). That, by the way, is approximately a 12,000 times higher mortality rate than that of the recent peanut paste salmonella outbreak. Which is interesting because while the Peanut Corporation of America just filed for bankruptcy, Merck & Co. seems to be doing just fine. But, I digress.
If you question the impact of Vioxx on the public's health, check out the U.S. mortality rates in 2003 versus 2004. In 2002, the U.S. Food and Drug Administration (FDA) issued a warning on Vioxx's safety and this led to a 30 percent decrease in prescriptions (6 million) from 2003 to 2004. Interestingly, 2004 also saw a 2 percent decrease (over 50,000) in the total number of U.S. deaths. This drop in mortality was surprising for several reasons:
- It was the largest in 70 years.
- Most of it was in heart-disease related mortality (which decreased by 6.6 percent), despite the fact that there were no major widespread improvements in cardiac care in 2003 or 2004.
- It occurred despite the continued aging of the U.S. population.
- It was not a one-year statistical fluke (there was no major increase in mortality in 2005).
As those who've followed the Vioxx saga know, the real tragedy lies in the fact that, from the beginning, there was evidence that the drug increased the risk of heart attacks. Because of a combination of selective reporting of the data, overly optimistic interpretations of results, ghostwriting of manuscripts, inattentive editing, and aggressive and disingenuous marketing, this evidence was ignored.
I have to think that a well-funded and unbiased CER could have exposed Vioxx's fatal flaw before the death count escalated into the tens of thousands. Even if based only on early studies, a comparison of Vioxx and other available treatments would have revealed that most patients would receive little, if any, benefit by using Vioxx. But since such a comparison did not exist, Merck representatives were able to convince many physicians that they should prescribe Vioxx to patients who didn't need it, and advertising convinced many patients that Vioxx was a miracle drug that they had to have. While the FDA certainly dropped the ball on the safety of Vioxx (and has since tried to improve public access to safety and efficacy information), CER could have greatly mitigated the damage.
So yes, a Council for CER might be "dangerous" - but to companies that disregard the public health in order to make money on ineffective or harmful treatments.
Dr. Dustin Ballard is an emergency physician practicing in Marin County and the author of "The Bullet's Yaw: Reflections on Violence, Healing and an Unforgettable Stranger." His Medically Clear column appears every other Monday.